MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY; CORONARY DRUG-ELUTING STENT

Model Number 10618

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Arteriosclerosis/ Atherosclerosis (4437)

Event Date 07/28/2022

Event Type  Injury  

Event Description

Synergy china registry.It was reported that coronary atherosclerotic heart disease occurred.In (b)(6) 2019, the subject presented with myocardial infarction and was referred for cardiac catheterization.Index procedure was performed.The target lesion was located in the mid left anterior descending (lad) with 100 % stenosis and was 16 mm long, with a reference vessel diameter of 2.5 mm.The target lesion was treated with pre-dilatation and placement of 2.50 mm x 16 mm synergy stent system.Following post dilatation, residual stenosis was 0%.Seven days later, in (b)(6) 2020, the subject was discharged on aspirin and ticagrelor.In (b)(6) 2022, the subject was diagnosed with coronary atherosclerotic heart disease and was hospitalized on the same day for further evaluation and treatment.Medication was given to treat the event.Five days later, the event was considered to be recovered and resolved.The subject was discharged on the same day on aspirin and ticagrelor.

• Brand Name: SYNERGY
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16013623
• MDR Text Key: 305786989
• Report Number: 2124215-2022-51485
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2020
• Device Model Number: 10618
• Device Catalogue Number: 10618
• Device Lot Number: 0023308754
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/01/2022
• Initial Date FDA Received: 12/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/30/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR
• Patient Sex: Male